Manufacturing Supervisor, Drug Substance Manufacturing

Fujifilm•Holly Springs, NC

1d•Onsite

About The Position

As an Upstream or Downstream Supervisor, you will lead and develop a team of manufacturing associates supporting the startup and ongoing operation of a large-scale biopharmaceutical facility. You will build team capability, execute training plans, support commissioning, qualification, and operational-readiness activities, and ensure work is performed safely, consistently, and in compliance with cGMP requirements. You will also coordinate cross-functional activities, manage shift priorities and escalations, maintain controlled documentation, support investigations and corrective actions, and drive continuous improvement. During operations, you and your team will work a 2-2-3, 12-hour shift schedule to support reliable manufacturing performance. This is an opportunity to help launch a new facility and establish a strong culture of safety, quality, and operational excellence.

Requirements

High school diploma or GED.
8 or more years of experience in a similar role within large-scale pharmaceutical, biotechnology, or related manufacturing operations or project environments.
Experience leading, supervising, or managing employees.
Experience working in a regulated manufacturing environment.

Nice To Haves

Bachelor’s degree in life sciences with 4 or more years of experience in a similar role within large-scale pharmaceutical or biotechnology operations or projects; OR
Associate degree in life sciences with 6 or more years of relevant experience; OR
Equivalent military experience.
Experience manufacturing biological products.
Familiarity with GMP and GLP requirements.
Experience supporting commissioning, qualification, startup, operational readiness, or manufacturing operations.
Demonstrated ability to lead teams, coordinate cross-functional activities, and manage competing priorities in a fast-paced environment.

Responsibilities

Support commissioning and qualification activities in preparation for manufacturing operations.
Lead and support operational-readiness activities, including document review and approval, team onboarding, materials management, and cross-functional coordination.
Develop and execute a training plan to prepare the team for initial GMP production.
Lead, mentor, and develop team members through onboarding, training, regular communication, and performance support.
Administer company policies that directly impact employees, including travel and expense, time reporting, time off, and other applicable workplace policies.
Coordinate with cross-functional support groups to ensure readiness for startup activities.
Provide on-the-floor leadership for a shift team of approximately 7–10 manufacturing associates.
Coordinate execution of the manufacturing schedule through daily shift assignments, shift huddles, and timely escalation management.
Foster an inclusive, people-first culture through regular communication, team engagement, and recurring one-on-one meetings focused on employee development and success.
Promote a strong safety and quality culture by conducting Gemba walks, reinforcing safe work practices, and ensuring direct reports maintain current, role-appropriate training.
Maintain a compliant cGMP manufacturing environment and ensure work is performed in accordance with applicable procedures, policies, and regulatory requirements.
Support manufacturing investigations, root-cause analysis, corrective and preventive actions, and continuous improvement initiatives.
Coordinate with maintenance, calibration, and other functional groups requiring access to manufacturing areas, equipment, or systems.
Administer employee policies affecting manufacturing operations, including time reporting, time off, shift policies, and inclement weather procedures.